2008 505(b)(2) Approvals

Published On: February 5, 2009

For the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively. The FDA publishes a list of drugs approved each year and this list for approvals through November, 2008 has a column “505(b)(2) Flag”. We have found this column to be unreliable – several rows of (b)(1)’s are checked with a (b)(2) flag. The following table was compiled by reviewing the approval documents for all new drugs approved in calendar 2008; these documents can be found by following the hyperlink for each drug product.

Established NameProprietary NameApplicantApproval

New Molecular Entities

Bendamustine Hydrochloride

Treanda

Cephalon

20-Mar-08

Fospropofol Disodium

Lusedra

Eisai Medical Research

12-Dec-08

Iobenguane I 123 Injection

AdreView

GE Healthcare

19-Sep-08

New Esters, Salts, or Other Noncovalent Derivatives

Bupropion Hydrobromide

Aplenzin

Biovail Labs

23-Apr-08

Fenofibric Acid

Trilipix

Abbott

15-Dec-08

Granisetron Transdermal System

Sancuso

Strakan

12-Sep-08

New Formulations

Abacavir Sulfate; Lamivudine

Abacavir Sulfate

Aurobindo Pharma Ltd

19-Dec-08

Amiodarone Hydrochloride

Nexterone

Prism Pharma

24-Dec-08

Amoxicillin

Moxatag

Middlebrook

23-Jan-08

Cefepime Injection

Cefepime Injection

Baxter

05-Aug-08

Efavirenz

Efavirenz

Aurobindo Pharma Ltd

12-Dec-08

Fluorescein Injection

Ak-Fluor

Akorn

08-Aug-08

Lidocaine Hydrochloride

Akten

Akorn

07-Oct-08

Mesalamine

Apriso

Salix

31-Oct-08

Phentolamine Mesylate

Oraverse

Novalar

09-May-08

Prednisolone Acetate

Flo-Pred

Taro

17-Jan-08

Triamcinolone Acetonide

Trivaris

Allergan

16-Jun-08

Valproic Acid

Stavzor

Banner

29-Jul-08

Venlafaxine Hydrochloride

Venlafaxine Hydrochloride

Osmotica

20-May-08

Zolpidem Tartrate

Zolpimist

Novadel

19-Dec-08

New Combinations

Adapalene; Benzoyl Peroxide

Epiduo

Galderma Labs

08-Dec-08

Niacin/Simvastatin

Simcor

Abbott

15-Feb-08

Repaglinide/Metformin Hydrochloride

PrandiMet

Novo Nordisk

23-Jun-08

Sumatriptan; Naproxen Sodium

Treximet

Pozen

15-Apr-08

New Formulation and New Combination

Methyl Salicylate & Menthol

Salonpas

Hisamitsu

20-Feb-08

Drug Already Marketed, but Without an Approved NDA

Morphine Sulfate

Morphine Sulfate

Roxane

17-Mar-08 (2 NDAs)

Tentative Approvals

Docetaxel Injection

Docetaxel Injection

Hospira Inc

11-Aug-08

Pantoprazole Sodium

Pantoprazole Sodium

Teva Parenteral

20-Oct-08

Based on the number of NDA’s that Camargo is compiling for just our clients, we expect 505(b)(2) to dominate the approval list in 2009. Looking at the number of IND’s we are filing, we expect that by 2012, the percentage of 505(b)(2) approvals will be greater than 90%.

“I recently commented to our Camargo lead that all virtual biopharma companies should engage Camargo as a strategic partner. It is not only the depth of regulatory experience—meeting with the FDA five to six times a month—and the breadth of functional expertise, but also their responsiveness. Camargo is a key strategic partner that will help us succeed and bring our life-saving products to market.”